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A Bioequivalence Study of Hetrombopag in Healthy Subjects

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05088655
Collaborator
(none)
57
Enrollment
1
Location
3
Arms
14.2
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hetrombopag Olamine Tablet
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
Actual Study Start Date :
Jun 25, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A: T - R- R

Drug: Hetrombopag Olamine Tablet
Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
Experimental: Treatment group B: R -T - R

Drug: Hetrombopag Olamine Tablet
Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
Experimental: Treatment group C: R- R-T

Drug: Hetrombopag Olamine Tablet
Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)

Outcome Measures

Primary Outcome Measures

  1. Peak plasma concentration (Cmax) [0-120 hours post dose]

  2. Area Under the plasma concentration vs time curve (AUC0-120) [0-120 hours post dose]

  3. area under the plasma concentration vs time curve (AUC0-inf) [0-infinity]

Secondary Outcome Measures

  1. Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) [0-120 hours post dose]

  2. Half-life Associated With the Terminal Slope (t½) [0-120 hours post dose]

  3. The number of volunteers with adverse events as a measure of safety and tolerability [up to Day 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;

  2. Ability to complete the study as required by the protocol;

  3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;

  4. Body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

  1. Allergic constitution;

  2. History of drug use, or drug abuse screening positive;

  3. Alcoholic or often drinkers;

  4. History of deep vein thrombosis, or any other thromboembolic event;

  5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The People's Hospital Of Liaoning Province Shenyang Liaoning China 110016

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05088655
Other Study ID Numbers:
  • SHR8735-114
First Posted:
Oct 22, 2021
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anemia, Aplastic

Study Results

No Results Posted as of Jun 28, 2022